Neoadjuvant Accelerated Short Course Radiation Therapy With Proton Beam and Capecitabine for Resectable Pancreatic Cancer

Browse trials for

• Pancreatic Neoplasms 3,235

Keywords

• accelerated short course
• proton beam radiation

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 50 is close to the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Study arms

• Experimental
  Group 1

  10 Radiation Sessions over 2 weeks

  Procedure: Proton Beam Radiation · Drug: Capecitabine

• Experimental
  Group 2

  5 Radiation sessions: 3 in week 1 and 2 in week 2

  Procedure: Proton Beam Radiation · Drug: Capecitabine

• Experimental
  Group 3

  5 Radiation sessions: 4 in week 1 and 1 in week 2

  Procedure: Proton Beam Radiation · Drug: Capecitabine

• Experimental
  Group 4

  5 Radiation Sessions in one week

  Procedure: Proton Beam Radiation · Drug: Capecitabine

Interventions

• ProcedureProton Beam Radiation

  Given over different schedules and duration

• DrugCapecitabine

  Given orally starting on day one of radiation therapy for 2 weeks

Primary outcomes

1. Number of Participants With Dose Limiting Toxicities in the 5 Radiation Sessions in One Week Arm

   The number of participants that experienced a dose limiting toxicity in the arm where radiation was administered over 5 consecutive for a total dose of 25 Gray Equivalents (GyE) (Group 4). Participants were monitored for potential Dose Limiting Toxicities (DLT) for three weeks after the start of radiation. DLTs included: 1. Any grade 3 non-hematologic or hematologic toxicity requiring a greater than 7 day interruption in therapy (excluding alopecia and nausea/vomiting not controlled by optimal supportive care or 2. Any grade 4 non-hematologic toxicity or 3. Any grade 4 neutropenia or thrombocytopenia as defined by Common Terminology Criteria for Adverse Events (CTCAE v3.0)

   Time frame: 3 Weeks

2. Number of Participants With Grade 3 or Greater Toxicity in Phase II

   Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). The regimen was considered to be tolerated if less than 20% of participants experienced a grade 3 or greater toxicity.

   Time frame: 30 days after the end of treatment, up to approximately 6 months total

Secondary outcomes

1. Number of Participants With a Pathological Complete Response

   All patients that received surgery underwent a full pathological review of their pancreaticoduodenectomy specimen according to the American Joint Committee on Cancer (AJCC) Staging Classification, 6th. Initial gross evaluation and identification of resection margins was performed jointly by the surgeon and the pathologist. Pathological complete response will be defined as the absence of any viable tumor cells within the pathologic specimen.

   Time frame: at the time of surgery (28-42 days after start of treatment)

2. Median Progression Free Survival

   The median amount of time from the start of treatment until death or disease progression, whichever occurs first. Progressive Disease (PD): A 20% or greater increase in the sum of Longest Diameter (LD) of all target lesions, taking as reference the smallest sum LD recorded since baseline.

   Time frame: from the start of treatment until death or progression, median duration of 10.4 months

3. Number of Participants With Surgical Morbidity

   Number of participants with pancreatic or any other anastomotic leakage within 30 days of surgery

   Time frame: 30 days post surgery (surgery was 28-42 days after the start of treatment)

4. 30-Day Post Operative Mortality

   The number of participants that died within 30 days of undergoing a pancreaticoduodenectomy.

   Time frame: 30 days after the time of surgery (Surgery is 28-42 days after start of treatment)

5. Number of Participants With Treatment Related Serious Adverse Events

   The number of participants that had treatment related serious adverse events. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 3). Adverse events were considered to be serious adverse events if they were grade 3 or greater and were considered to be possibly, probably, or definitely related to treatment.

   Time frame: From the start of treatment until 30 days after the end of treatment, up to approximately 5 months

Baseline characteristics

Publications

• Hong TS, Ryan DP, Borger DR, Blaszkowsky LS, Yeap BY, Ancukiewicz M, Deshpande V, Shinagare S, Wo JY, Boucher Y, Wadlow RC, Kwak EL, Allen JN, Clark JW, Zhu AX, Ferrone CR, Mamon HJ, Adams J, Winrich B, Grillo T, Jain RK, DeLaney TF, Fernandez-del Castillo C, Duda DG. A phase 1/2 and biomarker study of preoperative short course chemoradiation with proton beam therapy and capecitabine followed by early surgery for resectable pancreatic ductal adenocarcinoma. Int J Radiat Oncol Biol Phys. 2014 Jul 15;89(4):830-8. doi: 10.1016/j.ijrobp.2014.03.034. Epub 2014 May 24. PubMed 24867540 ↗

Study documents

• Protocol and statistical analysis plan · Jun 18, 2010

Documents are hosted by the registry — open the source record to download them.